Biometrics

Data Management

Our partnered company in Data Management & Biostatistics oversees all facets of collecting and processing clinical data, employing fully integrated applications and systems. They closely collaborate with our clinical teams to ensure alignment on all aspects of study delivery. Our service is tailored to be flexible and bespoke, allowing for the swift implementation of changes to accommodate protocol amendments during the study.

To guarantee the integrity and security of data, all our processes strictly adhere to 21 CFR Part 11 compliance standards. We uphold the highest quality measures and integrate CDISC standards into our data reporting activities. This commitment to regulatory compliance, data integrity, and industry standards reinforces our dedication to delivering reliable and high-quality outcomes in the management and analysis of clinical trial data.

• Source document preparation
• eCRF design and development
• Database build and testing
• Creation, development and maintenance of all study documents specific to data management
• Online training for all clinical database users
• Discrepancy management preparation and testing
• Medical dictionary coding (WHODRUG and MedDRA)
• SAE reconciliation
• External data reconciliation with our vendor management team
• Quality control
• Database lock
• Biometrics Data Management
• Biostatistics and SAS Programming
• Randomization Chart
• Sample size calculation

Our staff are focused on identifying optimal study design, efficacy measures, and standard reproduceable outcomes